510(k) K103735
K103735 is an FDA 510(k) premarket notification submitted by Medix I.C.S.A. for the device "MEDILED MINI". The FDA issued a decision of Substantially Equivalent on August 15, 2011. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Medix I.C.S.A. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2011
- Date Received
- December 22, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Neonatal Phototherapy
- Device Class
- Class II
- Regulation Number
- 880.5700
- Review Panel
- HO
- Submission Type